Catalog Number

-

Brand Name

Albahealth

Version/Model Number

B53558G12100304

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123308,K123308

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

3ce38f1d-d2d3-4e82-89d2-72870a8c3def

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

50073614762164

Quantity per Package

24

Contains DI Package

00073614762169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-